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April 23, 2021

FDA grants 510(k) clearance to Getinge’s ventilator software options

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Getinge’s new software options for the Servo-u and Servo-n ventilators as well as the novel Servo-u MR ventilator for the MRI room.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Getinge’s new software options for the Servo-u and Servo-n ventilators as well as the novel Servo-u MR ventilator for the MRI room.

Getinge North America president Eric Honroth said: “The Covid-19 pandemic and the heightened awareness of respiratory health have driven the need for personalised ventilation solutions for critically ill patients.

“Now more than ever, options for personalised lung protection and personalised weaning solutions are at the forefront of respiratory patient health.”

The software upgrade for the Servo-u and Servo-n adds various new functionalities and options across adult, paediatric and neonatal patient categories.

The latest development expands the company’s portfolio of lung-protective tools, which includes a standardised and automated workflow for directing lung recruitment called Automatic Stepwise Recruitment Manoeuvre (Auto SRM). This aids clinicians in detecting a customised positive end-expiratory pressure (PEEP) that offers the lowest driving pressure, which is linked to patient survival in acute respiratory distress syndrome (ARDS) cases.

The lung-protective toolkit has a stress index and transpulmonary pressure monitoring, including crucial parameters for evaluating lung stress during controlled and spontaneous ventilation. This could aid in dividing the cognitive workload optimally between the clinician and the ventilator.

Furthermore, the clearance includes Heliox therapy, which combines helium and oxygen to help laminar flow and reduce airway pressure through its low density. The company claims this aids in lowering the work of breathing (WoB) in patients with obstructive lung diseases.

The company has also received clearance to launch the Servo-u MR in the US market, which will complement the Servo family and expand its platform of ventilators into the MRI room.

The Servo-u MR has a magnetic field indicator with visual and audible alerts as well as an auto-lock handle that locks all four wheels on releasing the ventilator.

Getinge noted that the novel options and the Servo-u MR ventilator are anticipated to be available in the US in July.

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